ESMO Releases Statement in Support of Biosimilars, Citing Cost-Savings and Cost-Effectiveness

Monday, January 30, 2017

The European Society for Medical Oncology (ESMO) published a position paper in support of biosimilar agents, noting that they are effective, affordable, and, according to ESMO President Fortunato Ciardiello, MD, PhD, essential tools for providing financially sustainable cancer care.

“Biosimilars are must-have weaponry in financially sustaining health-care systems on a global scale, as well as significantly improving outcomes for an increasing number of patients throughout Europe and the rest of the world,” said Dr. Ciardiello.

“Biosimilars are an excellent opportunity to have good, valid drug options that improve the sustainability and affordability of cancer treatment in various countries,” added Josep Tabernero, MD, PhD, chair of the ESMO Cancer Medicines Working Group.

Biosimilars are medicinal products derived from living organisms that contain a similar version of the active substance as the original biologic. However, unlike generics, biosimilars require clinical studies to ensure that the manufacturing process is sound and does not differ from that of the original biologic. Europe leads the United States in introducing regulatory pathways for biosimilars, and the first biosimilar cancer agents are expected to reach the European market this year.

The recently published position paper outlines approval standards for biosimilars, how to safely introduce them into the clinic, and the potential benefits for patients and health-care systems. The paper also tackles issues surrounding labeling of biosimilars, the ability to extrapolate data from reference product research, and interchangeability, substitution, and switching between biosimilar and reference products.

ESMO also noted that price discounts for biosimilars could reach 20 to 40 percent in Europe, with potential savings of 50 to 100 billion euros ($53-107 billion) for the European health-care system by 2020.